2021 White Paper on Recent Issues in Bioanalysis: ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry ( <u>Part 2</u> – Recommendations on Biomarkers/CDx Assays Development & Validation, Cytometry Validation & Innovation, Biotherapeutics PK LBA Regulated Bioanalysis, Critical Reagents & Positive Controls Generation)
Sarah Hersey, Steve Keller, Joel Mathews, Lindsay King, Abbas Bandukwala, Flora Berisha, Mary Birchler, Joe Bower, Valerie A. Clausen, José M. Duarte, Fabio Garofolo, Shirley Hopper, Sumit Kar, Omar S. Mabrouk, Jean‐Claude Marshall, Kristina McGuire, Michael Naughton, Yoshiro Saito, Imelda Schuhmann, Gizette Sperinde, Priscila Camillo Teixeira, Alessandra Vitaliti, Yow‐Ming Wang, Richard Wnek, Yan Zhang, Sue Spitz, Vilma Decman, Steven Eck, Jose Estevam, Polina Goihberg, Enrique Gómez Alcaide, Christèle Gonneau, Michael N. Hedrick, Gregory Hopkins, Fabian Junker, Sandra Nuti, Ülrike Sommer, Nathan Standifer, Chad Stevens, Erin Stevens, Carrie A. Hendricks, Meenu Wadhwa, Albert Torri, Mark Ma, Shannon Harris, Seema Kumar, Michael A. Partridge, Teresa Caiazzo, Shannon Chilewski, Isabelle Cludts, Kelly Coble, Boris Gorovits, Christine Grimaldi, Gregor Jordan, John Kamerud, Beth Leary, Meina Liang, Hanjo Lim, Andrew P. Mayer, Ellen O’Connor, Nisha Palackal, Johann Poetzl, Sandra Prior, Mohsen Rajabi Abhari, Natasha Savoie, Catherine Soo, Mark Ware, Bonnie Wu, Yang Xu, Tong‐Yuan Yang, Jad Zoghbi
Abstract
The 15th edition of the Workshop on Recent Issues in Bioanalysis (15th WRIB) was held on 27 September to 1 October 2021. Even with a last-minute move from in-person to virtual, an overwhelmingly high number of nearly 900 professionals representing pharma and biotech companies, contract research organizations (CROs), and multiple regulatory agencies still eagerly convened to actively discuss the most current topics of interest in bioanalysis. The 15th WRIB included three Main Workshops and seven Specialized Workshops that together spanned 1 week in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy, cell therapy and vaccines. Moreover, in-depth workshops on biomarker assay development and validation (BAV) (focused on clarifying the confusion created by the increased use of the term "context of use" [COU]); mass spectrometry of proteins (therapeutic, biomarker and transgene); state-of-the-art cytometry innovation and validation; and critical reagent and positive control generation were the special features of the 15th edition. This 2021 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop, and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2021 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 2) covers the recommendations on ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry. Part 1A (Endogenous Compounds, Small Molecules, Complex Methods, Regulated Mass Spec of Large Molecules, Small Molecule, PoC), Part 1B (Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine) and Part 3 (TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness) are published in volume 14 of Bioanalysis, issues 9 and 11 (2022), respectively.